People often pursue projects involving data. Businesspeople may have business deals, students may have term projects, engineers may have building projects, and teachers may have courses to plan. Each of these projects may have a life-cycle that includes several stages or phases, such as strategy, planning, execution, and review. Each of these phases may involve different tasks or workflows, and the people performing these tasks may take on different roles within the project. A business deal may involve a project manager, a banker, a lawyer, and an accountant; a term project may involve a planner, a designer, a writer, and a builder; a building project may involve a project manager, a financier, a planner, an engineer, and a technician; and a course plan may involve a main teacher, a teacher's aide, students, and a principal. Individuals may sometimes take on multiple roles within a single project.
People (or entities) pursuing such projects often use computer programs to manage the data. These programs often include a suite of applications, and the people or entities may choose a specific application based on the task or workflow that they want to perform. These suites often do not allow users to easily switch between applications, for example because they request the users to provide credentials every time they access the application. Moreover, sometimes a user wants to view the same data, such as a table, using different applications, such as a word processing application, a spreadsheet application, and a presentation application, but the suite requires the user to open up each application separately, which can be very tedious.
Performing a clinical trial to determine the safety and effectiveness of a pharmaceutical drug or medical device is another example of a project that generates much data and that often uses a suite of computer applications to manage the data. In a clinical trial (called a “clinical study” or “study” in this specification) for a drug, subjects are given doses of the drug and the subject's reaction to the drug is recorded. For a single drug, there may be more than one clinical study, each of which may be carried out with many subjects and at a number of different sites. A clinical study also has a life-cycle made up of phases and involves different people performing various tasks or workflows (or even the same people having multiple roles). The life-cycle of a clinical study may include the design phase, the execution phase, the data collection and analysis phase, and the submission phase. The entities involved may include a sponsor, a principal investigator (PI), contract research organization (CRO), subjects or patients, and regulatory authorities. In many cases, the sponsor is the drug or device manufacturer, such as a pharmaceutical company, but the sponsor may also be an academic medical or research center, a Federal agency such as the National Institutes of Health (NIH) or Departments of Defense or Veterans Affairs, a clinical research center, or a physician or other health care provider. The principal investigator (PI) leads the study and is often a medical doctor, and may also include a research team that comprises doctors, nurses, social workers, and other health care professionals. The clinical study is often administered by the CRO, which may be a person or an organization—commercial, academic, or other—who is contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions. Regulatory authorities, which may include the United States Food and Drug Administration (FDA) and its foreign counterparts, may set the rules by which the clinical studies operate and may be the authorities to whom data are submitted to approve the drug or device.
Each of the users or entities involved with a clinical study may perform many different tasks during the stages of the clinical study. Various software programs have been developed to perform these tasks, but the programs are often usable for only specific stages of a specific study and for a user's specific roles or permitted uses of that software. If a user wants to perform a different task or take on a different role in a study, the user is required to use different programs, often needing to provide credentials when accessing each program. Moreover, sometimes the same data are accessed, viewed, or modified using different programs based on the task to be performed or the role being played, and it is inefficient and somewhat tedious to access individual programs even when operating on the same data.
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